The Fda vs. Recycling:
Has Food Packaging Law Gone Too Far?

My name is Alexander Volokh of the Reason Foundation, and I'm
going to be talking to you about food packaging regulation.

Food packaging is not a sexy topic. I know of only one instance
where it has affected popular culture in a lasting way. This is
in The Music Man, the musical by Meredith Willson and Jerry
Herman, where in the opening piece, traveling salesman from the
turn of the century discuss how the trappings of modern society
have changed their profession. In that piece, one salesman
describes the effect of food packaging: "Why it's the Uneeda
Biscuit made the trouble. Uneeda, Uneeda, put the crackers in
the package, in the package, the Uneeda Biscuit in an airtight,
sanitary package, made the cracker barrel obsolete, obsolete."
At this, the other salesmen chime in in agreement: "Obsolete,
obsolete, obsolete."

Most people, though, don't find food packaging very interesting,
and this is a shame. Food packaging is living proof that some of
the most wonderful, life-enhancing, freedom-increasing
innovations happen in some of the most mundane-seeming areas.
And people who don't appreciate the crucial role that food
packaging plays in our lives are unlikely to spend much time
critically evaluating the regulations the food packaging industry
lives under, or feel outrage when such regulations go overboard.
Many people have strong feeling in general about the FDA; some
folks excoriate the FDA for allowing people to take drugs that
can kill them, while others bash the FDA for not allowing people
to take drugs that might save them. Most of these people are
silent when it comes to FDA regulation of food packaging. Who
ever got excited over a Coke bottle?

But food packaging is your life, and the silent miracles of
packaging innovation touch the lives of your customers, and their
customers, all the way down to me, the supermarket shopper. Of
all the areas regulated by the FDA, I think food packaging is the
field where the FDA is most reasonable and gets it right most
consistently. Still, there are some major problems, which I will
try to point out to you today in the context of recycled
plastics. As a wise man once said, "I think sometimes the FDA
lives in an ivory tower."

* * *

Most of you probably already know the surprising, and counter-intuitive,
nature of food packaging law. Packaging isn't a food,
it's not a drug, and it's not a cosmetic, but the FDA still
regulates it under the Food, Drug, and Cosmetic Act. Officially,
food packaging is regulated as a food additive. Unlike
NutraSweet and Yellow #5, food packaging isn't intended to do
anything to the food. But by the Second Law of Thermodynamics,
substances diffuse over time, so given enough years, the
components of the Coke bottle will become part of your Coke, and
vice versa. So the components of food packaging law are
regulated as "indirect food additives."

The most surprising aspect of food packaging law as it relates to
recycled materials is that there isn't really any. The Food,
Drug, and Cosmetic Act doesn't mandate any special regulatory
review or additional FDA clearance for recycled materials. This
is because the FDA regulates food-contact materials based on
their composition, and based on the identity and amount of the
material that can migrate to food -- not based on whether the
materials are virgin or recycled plastic. Any recycled material
can be used if it complies with current regulatory requirements.

The trouble, though, is that the people who wrote the original
regulations weren't really thinking about recycled materials.
The regulations assume that packaging is being made out of virgin
materials, or out of materials that come from a controlled source
(rather than recycled materials, which could come from thousands
of unknown sources). Materials have to be "suitably pure," but
the regulations doesn't say how "suitable" is "suitable." For
instance, the regulations officially allow recycled paper and
paperboard as long as neither "bears or contains any poisonous or
deleterious substance which is retained in the recovered pulp and
that migrates to the food." This is a very general statement,
and could be interpreted as requiring a zero tolerance for
contaminants. In fact, FDA regulation of recycled materials has
been a mixture of discretion, rulemaking, and informal opinion
letters. These informal opinion letters are called "non-
objection letters."

* * *

At first, food packaging developers didn't have much guidance as
to what to expect from the FDA. They submitted their best guess
as to what the FDA wanted, and hoped that the FDA would issue a
non-objection letter. Sometimes, the FDA would respond by asking
for more information, and the whole process took several months.
The FDA issued guidance documents, which informally established
that chemicals with dietary concentrations below 0.5 parts per
billion (ppb) -- that is, chemicals which could be expected to be
less than one two-billionth of your entire diet -- were O.K. In
reality, though, because of the conservatism of the FDA testing
procedures, the actual dietary concentration is much, much lower
than whatever the testing might reveal. As the FDA put it,
testing assumed various worst-case scenarios; all material
entering the waste stream was assumed to be contaminated.

In October 1993, the FDA announced that it was considering
adopting a "threshold of regulation" for food additives; the rule
became final in July 1995. The FDA has already been following
this rule informally for a few years. Under the threshold of
regulation policy, certain substances are formally exempted from
regulation as food additives. To qualify for the exemption:

The substance shouldn't be carcinogenic, because the
use of carcinogens as food additives is prohibited by
the Delaney Clause. There should also be no reason to
suspect, based on the substance's chemical composition,
that it might be a carcinogen.

The expected concentration of the substance in the diet
should be less than 0.5 ppb. If the substance is
already also being regulated as a direct food additive,
then the amount of the substance that gets into food
through the packaging should be no more than 1 percent
of that substance's acceptable daily intake.

The substance should have no technical effect in or on
the food.

The use of the substance should have no significant
adverse effect on the environment.

Thresholds of regulation are necessary because with advancing
technology, instruments can detect smaller and smaller amounts of
any substance. But just because they're there doesn't mean
they're dangerous. The threshold of regulation standards are the
ones now being used to judge non-objection letter requests.
Substances that fail these conditions can still be approved, but
they need to go through the regular food additive process, which
takes a pretty long time.

* * *

As I've said before, food packaging regulation is one of the most
reasonably regulated areas of all the fields regulated by the
FDA. The reason it's reasonable is that it recognizes that the
dose makes the poison, and that a chemical that is dangerous in
high concentrations might be harmless at low ones. This
philosophy dates back at least to the 1979 case of Monsanto v.
Kennedy. In the late 1970s, Monsanto made a Coke bottle out of
an acrylonitrile styrene copolymer. The FDA had at first
approved the bottle, but after finding out some bad toxicity data
on acrylonitrile -- one of the components of the bottle -- it
withdrew its approval. Monsanto sued the FDA, because there was
so little acrylonitrile in the bottle that it could never pose
any real health risks. Ultimately, the court told the FDA that
food and drug law doesn't prohibit teensy-weensy amounts of
chemicals. This case was important because it established that
there's such a thing as a "reasonable expectation of no
migration." In the decade following the Monsanto case, as
analytical models became more sensitive to minute quantities of
chemicals, the FDA became more and more willing to say "this is
so small that we don't care." In the end, both consumers and
plastics companies came out ahead.

But even though FDA food packaging regulations are less
troublesome than they might be, they still exaggerate risk, and
they do so consistently. As a general rule, it makes sense that
recycled material should be more suspect than virgin material.
Recycled material usually comes from many sources, and as the
saying goes, "You don't know where it's been." Or what's been in
it. Recycled plastics are less "pure" than virgin plastics,
because they may contain trace amounts of the original contents
of the package, or whatever the previous consumer happened to
store in the container -- pesticides, gasoline, rat poison, and so
on.

Even so, it's important to make sure that our safety standards
aren't too strict. We should remember that whenever we tighten a
safety standard, we may improve safety, but at the cost of
shutting out potentially promising technologies. As we get safer
and safer, the increased safety from tightening the standards
gets smaller and smaller, while the costs get higher and higher.
Since recycled materials are potentially more troublesome than
virgin materials, an overconservative standard would hit recycled
materials harder, and shut recycled materials out of the market
altogether without improving safety.

One problem is that under the new, finalized threshold of
regulation policy, an environmental assessment has to be done
before a non-objection letter is issued. If the review goes
well, the FDA issues a "Finding Of No Significant Impact"
(FONSI). Otherwise, the FDA conducts a full-blown "Environmental
Impact Statement" (EIS). EISs take a very long time; for
instance, the FDA has spent seven years not completing an EIS on
polyvinyl chloride (PVC) bottles. The FDA has only had to
conduct an EIS twice in the last 30 years. But even the less
rigorous environmental assessments take time -- about three to six
months. Now that they're required, they could double the time
required to get a non-objection letter.

But the FDA's threshold of regulation continues to be
conservative in other ways as well. The Delaney Clause prevents
the FDA from approving a substance that causes cancer in any
laboratory animal except under certain circumstances, even though
it's a very large leap from cancer at high doses in a laboratory
animal and cancer at low doses in a person. If something causes
cancer in any laboratory animal, the FDA assumes that it causes
cancer in people, even though tests on mice and rats give
contradictory results 25 percent of the time, and people are more
different from mice and rats than mice and rats are from each
other. If many studies have been done on the same chemical, the
FDA chooses the most sensitive species, sex, and organ
combination for its carcinogenic potency. The FDA assumes that
there is no threshold below which a chemical is harmless. And if
testing methods don't find a chemical, the FDA doesn't assume
that it's not there; instead, it assumes that the concentration
of the chemical is just the limit of the detection method. In
other words, if a testing method can detect anything larger than
50 ppb, then a negative result is interpreted to mean a
concentration of exactly 50 ppb.

Some say the Delaney Clause may be repealed in whatever watered-
down FDA reform may come out of the current Congress, but that's
not certain, and as Samuel Goldwyn is said to have said, "I never
make predictions, especially about the future." As for the rest
of the conservative assumptions, they're pretty much entrenched
in government rulemaking procedures, and will be tough to change.
Is that much conservatism necessary? Given that we don't know
everything about toxicology, any one of the conservative
assumptions may be justifiable, but this many layers of
conservatism is ridiculous.

A bit paradoxically, the FDA has noted that the threshold of
regulation, which was supposed to lighten the agency's workload
by loosening regulations, may in fact end up tightening the
regulations instead, and increasing the agency's workload. It
used to be that any chemical with a concentration under 50 ppb
only required a rodent feeding study and a literature search to
find published studies on the substances' effects. Now, a
threshold level of 0.5 ppb would focus regulatory attention on
exposures far below 50 ppb.

And numbers like 0.5 ppb and 1 percent of the diet, while they
may be nice, round numbers, are in fact drawn out of thin air.
They were derived, in a circuitous way, from the standard
assumption that risks below one-in-a-million are acceptable while
risks above one-in-a-million aren't, but even that number is
drawn out of thin air. It's a convenient number to use, but it
plays into the myth that we need to have one standard for
everything and everyone, even though the food inside the package
may be far more dangerous than the package itself, even though
unregulated natural chemicals may pose far greater risks than the
regulated manmade ones, and even though people willingly, without
giving it a second tought, expose themselves to risks greater
than one-in-a-million every day.

These, in short, are the main problems behind the FDA's risk
assessment. According to Jerry Heckman, the general counsel of
the Society of the Plastics Industry, the system is "archaic,"
"unnecessarily demanding," and "inefficient in the use of
manpower and scarce resources." According to former FDA general
counsel Peter Barton Hutt, indirect additives need "a completely
separate and different process, with far less government
involvement." Reforming these areas should make a significant
difference to the development of new technologies, including
recycled-content food packaging applications.

* * *

It may seem, in all this, as though I'm arguing against safety.

In a sense, I'm not. As I've pointed out, the FDA follows risk-
assessment methods that consistently exaggerate risk. Given all
the levels of conservatism built into the process, the true risk
is almost guaranteed to be lower, perhaps significantly lower,
than the FDA's calculated risk.

Now, conservatism is not a bad thing, particularly with food. As
Charles Lamb put it, "I hate a man who swallows his food,
affecting not to know what he is eating. I suspect his taste in
other matters." Many of us are risk-averse in our daily lives,
and would feel uncomfortable if we took risks that were above our
risk threshold, whatever that was. Many of us even have
different risk thresholds for different activities.

But that's risk management. Those are decisions about how we
ought to respond to risks. Before we make these decisions, we
should have accurate information about what those risks are.
That's risk assessment. Conservatism can be useful and
beneficial at the risk management stage; at the risk assessment
stage, it's generally counterproductive. So in a sense, I'm not
arguing against safety. Rather, I'm arguing for a return to
accurate and honest calculations of risk. These honest
calculations will reveal that many food packaging applications,
especially applications with recycled content, are in fact a lot
less dangerous than they now appear.

But in another sense, yes, I am arguing against safety. Not
against safety as such, but against a particular safety ideology
that many people in the public health establishment are in the
grip of. This ideology holds (1) that chemicals in food, given
current technology, pose substantial health risks, (2) that
public health risks can and should be reduced to zero, or as
close to zero as we can possibly get, (3) that public safety is
the most important thing of all, and (4) that man-made substances
are more troublesome than natural substances.

This philosophy is easy and sounds plausible, but suffers from a
subtle but crucial defect, which is that it is wrong.

First, as I've pointed out in this talk, public health agencies,
including the FDA, the EPA, and state and local health and safety
agencies, consistently overestimate risk. Is the risk really
there? Let's consider. Before the Food Additive Amendments in
1958, there was never any dramatic health-threatening incident
like thalidomide in food packaging. No government or responsible
authority in the United States had ever raised serious concerns
about food packaging safety. Since 1958, there has not been a
single FDA case aimed at condemning or seizing food because of
hazardous packaging. What's more, market forces already do a
good job of regulating packaging. In most cases, problems are
signaled by a food taste or odor problem. No manufacturer would
use -- because few consumers would buy -- such a package.

Second, risk can never be reduced to zero. Everything has some
chance, however slight, of killing or injuring us, and there's
literally no way of avoiding that. We can make risks arbitrarily
small -- one in a million, one in a million, one in a trillion --
but we can't make them zero.

Third, we shouldn't even want to reduce risks to zero. Safety,
like everything else, comes at a cost, and any dollar spent on
reducing the risks of packaging is a dollar that can't be spent
on reducing other risks or otherwise improving the quality of
life. Any policy that puts safety above all other goals will
ultimately lead to unnecessary high costs and harm safety in the
long run.

And finally, it makes no sense to single out man-made chemicals
as evil while exonerating natural chemicals. There is more risk
of cancer in apple juice, peanut butter, and coffee than in the
containers they come in. This risk is all-natural, and people
accept it without reservations. A public policy that insists on
reducing the risks of packaging while still recognizing that
people have the right to choose coffee must have crooked
priorities.

So when we call for loosening FDA restrictions on packaging in
order to allow new and better technologies to flourish, including
recycled-content packaging, we're not arguing against real
safety. Instead, we're arguing against a fake, ideological
concept of safety, exaggerating risk, biased against man-made
chemicals, and driven by an unrealistic desire to reduce risks to
zero regardless of costs. We're arguing against a food packaging
law that has gone too far.

Alexander Volokh is the author of "The FDA vs. Recycling: Has
Food Packaging Law Gone Too Far?", a policy study available from
the Reason Foundation, 310-391-2245.